RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Viamet Pharmaceuticals, Inc. today announced that results from the Company’s REVIVE study, a Phase 2b clinical trial of VT-1161 in the treatment of patients with recurrent vulvovaginal candidiasis (RVVC), will be highlighted in an oral presentation at the upcoming Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held August 10 to 12 in Park City, Utah. The presentation will be given by Jack Sobel, M.D., one of the world’s foremost authorities on vaginal yeast infections, and a clinical investigator in the REVIVE clinical trial. VT-1161, a novel inhibitor of fungal CYP51, recently completed a Phase 2b trial for the treatment of RVVC, a common condition for which there are currently no approved therapies in the United States. It is estimated that RVVC afflicts 5 to 8 percent of women of child-bearing age, and can be a source of significant concern and discomfort leading to a negative impact on quality of life.
Additional details of the REVIVE study presentation are as follows:
|Title:||Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients with Recurrent Vulvovaginal Candidiasis|
Thursday, August 10, 2017, 1:45 pm – 1:55 pm (Mountain)
|Location:||Scientific Oral Presentation Session 1, Renoir Room, The Chateaux Deer Valley|
About the Phase 2b REVIVE study
REVIVE (REcurrent Vulvovaginal Candidiasis Inhibition: an Oral VT-1161 Tablet Evaluation) was a randomized, double-blind, placebo-controlled, 48-week clinical trial of VT-1161 in patients with RVVC. The trial evaluated two dose levels of VT-1161 (150 mg and 300 mg) administered once weekly for either 11 or 23 weeks, following an initial one-week daily loading dose period. The trial enrolled 215 patients at 32 sites throughout the U.S. At baseline, the mean number of vulvovaginal candidiasis episodes per patient in the prior 12 months ranged from 4.6 to 5.2 across the study arms. Patients were eligible to enroll in the trial if they had a documented history of RVVC, presented to the physician with a vulvovaginal candidiasis infection, and had completed treatment of the active infection with fluconazole, an antifungal agent approved in the U.S. for the treatment of vulvovaginal candidiasis. The primary efficacy endpoint was the proportion of subjects with one or more culture-verified vulvovaginal candidiasis episodes through 48 weeks.
VT-1161 is a potent and selective, orally-administered inhibitor of fungal CYP51 which recently successfully completed Phase 2b clinical trials for the treatment of onychomycosis, or fungal nail infection, and recurrent vulvovaginal candidiasis (RVVC), a common and difficult to treat infection in women of child bearing age. VT-1161 blocks the production of ergosterol, an essential component of the fungal cell membrane. In preclinical studies, VT-1161 has demonstrated broad-spectrum activity against both dermatophytes and Candida species, including those species that cause onychomycosis and RVVC. Given the clinical and preclinical profile of VT-1161, Viamet believes that it may avoid the side effects that limit the use of current oral antifungal therapies, such as liver toxicity and drug-drug interactions. The U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to VT-1161 for the treatment of RVVC.
Recurrent vulvovaginal candidiasis (RVVC) is defined as the occurrence of three or more episodes of vulvovaginal candidiasis within a 12-month period. RVVC is estimated to occur in 5% to 8% of women in the United States during their child-bearing years. The infection involves the vaginal mucosa and surrounding tissues and can be a source of significant discomfort. RVVC is ranked by patients above migraine and similar to asthma and chronic obstructive pulmonary disease with regard to its negative impact on quality of life and also results in a significant loss of work time. There are currently no approved therapies in the US for the treatment of RVVC.
About Viamet (www.viamet.com)
Viamet discovers and develops breakthrough therapies based on our leadership in metalloenzyme chemistry and biology. Our clinical portfolio includes novel agents to treat both chronic and life threatening fungal infections. We also leverage our metalloenzyme expertise in other therapeutic areas including oncology and orphan diseases. Focusing on the needs of patients and clinicians, we design our drug candidates to achieve superior efficacy and safety profiles compared to currently marketed drugs.
This press release includes forward-looking statements. Actual results may vary materially from these statements. There are many important risks affecting Viamet’s business, including that clinical trials may not be commenced, or if commenced, may not be successful, regulatory approvals may not be obtained and approved products, if any, may not achieve commercial success. The Viamet group of companies includes Viamet Pharmaceuticals Holdings, LLC and its operating subsidiaries, Viamet Pharmaceuticals, Inc., VPS-2, Inc., VPS-3, Inc. and Viamet Pharmaceuticals (Bermuda), Ltd. The Viamet group of companies are based in the Research Triangle Park region of North Carolina, USA and Hamilton, Bermuda.